A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TP-05 in Healthy Participants at High Risk of Tick Exposure
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 722
- 试验地点
- 19
- 主要终点
- The Incidence of Treatment Emergent Adverse Events From Baseline
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
详细描述
This is a randomized, double-blind, placebo-controlled study conducted in healthy adult participants prior to anticipated exposure to Lyme Borreliosis. Participants will be randomized to receive either TP05 or placebo according to a predefined dosing schedule. Safety will be evaluated through adverse event monitoring, clinical laboratory assessments, vital signs, and physical examinations. The study will consist of a screening period, a treatment period (up to 24 weeks) and a safety follow up period. Participants will be randomized to receive one of two treatment regimens of TP-05 or placebo. Participants will be followed up for approximately 15 months and evaluated further for tick bites or symptoms of Lyme borreliosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy adult participants aged 18 to 70 years
- •Able to provide written informed consent
- •Willing and able to comply with study procedures
- •At high risk of exposure to ticks
- •Contraceptive use by men and women consistent with local regulations
排除标准
- •Prior exposure to TP05 or any isooxazoline in the last 12 months
- •Known hypersensitivity to TP05 or related compounds
- •Clinically significant medical conditions that may interfere with study participation
- •Use of investigational products within 30 days prior to screening.
- •Received previous vaccination against Lyme borreliosis, including investigational vaccines intended to prevent Lyme borreliosis
- •Receiving long-term antibiotic therapy
- •Received active or passive immunization within 4 weeks prior to Day
- •Pregnant or breastfeeding individuals
研究组 & 干预措施
TP-05 (lotilaner) High Dose
Oral Tablet
干预措施: TP-05 (lotilaner) High Dose (Drug)
TP-05 (lotilaner) Low Dose
Oral Tablet
干预措施: TP-05 (lotilaner) Low Dose (Drug)
Placebo
Oral Tablet
干预措施: Placebo (Drug)
结局指标
主要结局
The Incidence of Treatment Emergent Adverse Events From Baseline
时间窗: From day 1 through the end of study follow-up, an average of 15 months.
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
Clinically Significant Changes From Baseline Chemistry Laboratory Tests
时间窗: From day 1 through the end of study follow up, an average of 15 months.
Number of participants with clinically significant changes in clinical laboratory tests
Clinically Significant Changes From Baseline Hematology Laboratory Tests
时间窗: From day 1 through the end of study follow up, an average of 15 months.
Number of participants with clinically significant changes in clinical laboratory tests.
Clinically Significant Changes From Baseline Vital Signs
时间窗: From day 1 through the end of study follow up, an average of 15 months.
Number of participants with clinically significant changes in vital signs.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs)
时间窗: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\].
Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures
时间窗: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\].
Clinically Significant Changes From Baseline QTC Interval
时间窗: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval
Clinically Significant Changes From Baseline QRS Interval
时间窗: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.
次要结局
- Concentration of Lotilaner in Whole Blood(From dose through study completion, an average of 15 months.)
- Terminal Elimination Half Life (t½) of Lotilaner(At protocol specified timepoints through end study treatment phase, an average of 28 weeks.)
- Area Under the Concentration Time Curve (AUC) of Lotilaner(At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.)
- Maximum Observed Concentration (Cmax) of Lotilaner(At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.)
- Time to Maximum Observed Concentration (Tmax) of Lotilaner(At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.)